FDA Moves against Steroid-Containing Supplements

Action Points

Explain to patients that the FDA is investigating a company that manufactures bodybuilding supplements that may contain steroids or steroid-like substances.

WASHINGTON, July 28 -- The FDA has launched an investigation into a company that markets and distributes bodybuilding products allegedly containing steroids or steroid-like substances.

Late last week the agency executed a search warrant for American Cellular Laboratories in Pacifica, Calif. It has also issued a warning letter to American Cellular, stating that the agency has found the company in violation of the Federal Food, Drug, and Cosmetic Act.

FDA also issued a public health advisory, warning consumers not to use any bodybuilding products represented as containing steroids or steroid-like substances.

"Although these products are marketed as dietary supplements, they are not dietary supplements, but instead are unapproved new drugs that have not been reviewed by the FDA for safety and effectiveness," Michael Levy, of the FDA Center for Drug Evaluation and Research, said at a media briefing.

"They are also considered misbranded drugs because their labeling is false and misleading."

The agency said it has received five adverse event reports involving use of the products, including one serious liver injury.

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